「포스트 코로나 시대 바이오헬스 분야 한국기업 미국진출 전략」 온/오프라인 세미나 (Washington DC, 주미한국대사관)

보건복지부 메디컬코리아 거점 공관 지원사업으로 개최하는 본 행사는 주미대사관이 주최하고, KAPAL과 진흥원 미국지사에서 공동으로 주관하는 바이오헬스 한국기업 미국진출 전략 세미나입니다.

주미대사관(김상희 공사참사관 총괄) 주최, KAPAL과 진흥원 미국지사 공동 주관

바이오헬스 한국기업 미국진출 전략 온/오프라인 세미나

시간
미국 (동부): July 15, 2021 (Thr) 7:00 – 8:00 PM EDT (1부, Dinner & Networking)
8:00 – 9:50 PM EDT (2부, Seminar – Online 생중계)
한국: 7월 16일 (금요일) 9:00 – 10:50 AM KST (Online webinar)

장소
워싱턴 DC 주미한국대사관 1층 대회의실
2450 Massachusetts Ave NW, Washington, DC 20008
* On site Seminar는 CDC(미국 질병통제예방센터) 기준으로 코로나 백신 완전 접종자에 한해 현장 행사 참석 예정입니다.

7th KAPAL On-Air Webinar (June 24, 2021, 9:00 – 10:30 PM EST)

2021 KAPAL–KHIDI Bio & Health Webinar Series는 한미생명과학인 협회 (KAPAL)와 KHIDI 미국지사 웨비나 시리즈입니다.

About this event

KAPAL 7th On-Air Webinar

(2021 KAPAL-KHIDI Webinar Series #2)

Title: Use of Real-World Data and Real-World Evidence in Drug Development

The 21st Century Cures Act established a program to evaluate the potential use of real-world evidence (RWE) to help to support the approval of a new indication for a drug approved and to help to support or satisfy post-approval study requirements. Accordingly, the FDA has been exploring the potential use of Real World Data (RWD) in regulatory decision making. This presentation will start with general overview of Real-World Data and Real-World Evidence in drug development and introduction to observational studies and causal inference. Th challenges with RWD/RWE will be discussed from multiple aspects including data quality, study design and statistical methods to adjust potential confounding. At the end of presentation, case studies will be presented.

About the presenter:

Joo-Yeon Lee, Ph.D.

Senior Statistical Reviewer, FDA

Joo-Yeon Lee, Ph.D. is a senior statistician of Division of Biometrics VII in the Office of Biostatistics in the Center for Drug Evaluation and Research at the FDA. She has received a B.S in statistics from Ewha Womans University, M.A and Ph.D. in Biostatistics from Brown University. Since joining FDA in 2007, Dr. Lee has been working as a pharmacometrics reviewer for new drug applications and a statistical reviewer for post-market drug safety studies. Dr. Lee has been playing a major role in many working groups on causal inference methods within the FDA. In addition, Dr. Lee has involved in FDA-led drug safety studies utilizing sentinel data and other data source such as UK Clinical Practice Research Datalink (CPRD) as a collaborator. Dr. Lee has taught the inverse probability weighting method with a case study at causal inference workshop at FDA in November 2017 and short courses at DIA/FDA Biostatistics Industry and Regulator Forum in April 2018 and ASA Biopharmaceutical section regulatory-industry statistics workshop in September 2020. Currently, Dr. Lee has main interest in the causal inference in observational studies, especially methods for sensitivity analysis for unmeasured confounder(s) and is an active member of quantitative bias analysis working group and serves as FDA statistical collaborator of FDA-funded project that aims to evaluate methods for assessment of potential for bias due to uncontrolled confounding.

7th KAPAL On-Air webinar materials

BIO KOREA 2021 (June 9 (Wed) – 21 (Mon), 2021)

BIO KOREA has been held every year since 2006 and serving as a business platform for international bio companies. Sponsored by the Ministry of Health and Welfare, BIO KOREA is a place of practical business correspondence as well as international information and technology exchange, invigorating the bio industry. In its 15th year of bringing together various international academics, professionals, and CEOs of global bio companies to obtain, exchange, and discuss diverse affairs, through exhibition, business forum(partnering), and conference.

BIO KOREA has been providing abundant opportunities to assure competitive edges within the convergence industry centered around biotechnology. We cordially invite you to attend BIO KOREA 2021 which will be held both online (June 9-21, 2021) and on-site (June 9-11, 2021).

www.biokorea.org

6th KAPAL On-Air Webinar (Apr 29, 2021, 9:00 – 10:30 PM EST)

2021 KAPAL–KHIDI Bio & Health Webinar Series #1

When: 04/29/2021, 9:00pm – 10:30pm (EST)
04/29/2021, 6:00pm – 7:30pm(PST)
04/30/2021, 10:00am – 11:30am(KST)

Speaker : Stanford Jhee (Corporate Vice President, Scientific Affairs, Parexel International)

Title: Accelerating Global drug development: Ethnobridging strategies for Asia.

Objectives

  1. Define and understand ethnic sensitivity issues in drug development
  2. Regulatory updates on Japan and China clinical trials and product registration
  3. Clinical pharmacology strategies for identifying ethnicity factors

6th KAPAL On-Air webinar materials will be posted later.

5th KAPAL On-Air Webinar (Dec 29, 2020, 8:00 – 9:30 PM EST)

2020년 카팔의 온에어웨비나 시리즈에서 주제가 되었던 내용을 정리하고 한해를 마무리하며 네트워킹하는 웨비나입니다.

About this Event

안녕하세요.

어느새 2020년을 마무리하고 2021년을 기다리는 시간이 돌아왔네요.  

연말연시 모든 가정과 일터에 읏음과 행복으로 가득하길 바랍니다. 2020년을 되돌아보면 예상치 않던 코비드19로 인해 우리 생활에 많은 변화와 어려움도 있었지만, 새로운 도전도 많았던 한해 같습니다.

다행히도 코비드19 백신에 초록불이 켜졌고, 치료제 개발에도 많은 좋은 뉴스들이 나오고 있으니, 앞으로는 더욱 밝은 내용의 뉴스들을 듣길 기대하며 2021년을 준비하는 마음입니다. 오랜 펜더믹 상황에 너무 마음과 몸이 지치셨겠지만, 조금 더 힘을 내어 우리 모두 건강하게 잘 이겨내길 진심으로 바랍니다.  

저희 카팔은 오는 12월 29일 (화요일 미국동부시간 오후 8시,서부 오후 5시, 한국 12/30일 오전 10시 )에  제 5 회 카팔 온에어 웨비나를 개최합니다.  

https://www.eventbrite.com/e/5th-kapal-on-air-webinar-tickets-132679623325

이번 웨비나에서는 2020년 한해동안 진행한 4회의 웨비나를 정리를 하여 발표준비하고 있습니다.  또한 소그룹 네트워킹 시간과 상품권 추천 (총 1000불상당)을 준비하였으니 바쁘시더라도 관심과 참석을 바랍니다.

카팔은 2020년 아래의 주제들로 웨비나를 4회 개최하였습니다. 

아래는 지난 KAPAL 온에 웨비나 링크입니다.

KAPAL 4th On-Air Webinar (매사추세츠)

KAPAL 3rd On-Air Webinar (캘리포니아)

KAPAL 2nd On-Air Webinar (메릴랜드)

KAPAL 1st On-Air Webinar (코비드 진단키트 EUA)

카팔의 더 많은 정보는 www.kapal.org 에서 보실 수 있습니다.